NDAINTRAVENOUSPOWDER
Approved
Jan 2025
Lifecycle
Growth
Competitive Pressure
8/100
Clinical Trials
5
Data completeness
5/8 — Partial
GRAFAPEX (treosulfan) by Medexus Pharmaceuticals is 12. First approved in 2025.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GRAFAPEX (treosulfan) is an intravenous alkylating agent approved on January 21, 2025, for hematopoietic stem cell transplantation conditioning. It works by alkylating DNA to achieve hematopoietic stem cell depletion, immunosuppression, and antitumor activity. The drug is administered as an IV powder and converts spontaneously to active epoxide intermediates under physiological conditions.
Growth3.6 years to LOE
Early-stage growth product with newly approved status offers opportunities for commercial expansion and team scaling in a specialized transplant market.
Mechanism of Action
12.1 Mechanism of Action Treosulfan is an alkylating agent. DNA alkylation is thought to be responsible for the cytotoxic activities of treosulfan. Treosulfan showed hematopoietic stem cell depleting activity as well as immunosuppressive and antitumor activity in mouse models of leukemia. 12.2…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.